Check out our Monthly Life Sciences Newsletter, which gathers information on recent and upcoming regulations and news related to the health and agriculture sector in Brazil.
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Demarest Life Sciences Team
On March 16, 2022, the Brazilian National Health Regulatory Agency (“ANVISA”) published Rule No. 120, of March 9, 2022 (“Rule No. 120/2022”). The new regulation updates the list of medicines exempt from medical prescription. The list is provided in Annex I of the Rule.
The Rule updates the list based on parameters established by the World Health Organization (WHO). Such update is essential to ensure that the list is aligned with the innovations of the pharmaceutical sector, since it encompasses all medicines that treat symptoms and minor ailments and thus do not require evaluation and prescription by a health professional.
On March 16, 2022, ANVISA published Rule No. 121, of March 9, 2022 (“Rule No. 121/2022“). The new Rule establishes the criteria for acceptance of test reports required in the analysis of requests for notification and registration of sanitizing products.
The Rule aims to set quality parameters to be met by companies that wish to register sanitizing products with the Agency, establishing which types of test reports will be accepted, their scope, necessary information, and form of presentation.
On March 16, 2022, ANVISA published Rule No. 122, of March 2022 (“Rule No. 122/2022”), which establishes inspection procedures in Good Clinical Practice (“GCP”) for clinical drug trials.
The new Regulation aims to harmonize, guide and verify compliance with the GCP for clinical drug trials, establishing an inspection process composed of 6 steps: (i) communication of the inspection to the sponsor; (ii) opening meeting; (iii) interview with the study team; (iv) visit to the facilities; (v) document analysis; and (vi) closing meeting.
The inspection will be carried out by ANVISA’s permanent staff, who must notify the site 15 days prior to the inspection. In the case of a complaint or suspicion of irregularities, the inspection will take place without prior notice.
Upon receiving the Inspection Report (formal document containing the inspectors’ observations), the sponsor is granted a period of 120 days to comment on the inspection. Once this period has elapsed, ANVISA must issue its final opinion, declaring whether the clinical study complies with the GCPs.
On March 16, 2022, ANVISA passed Rule No. 623, of March 9, 2022 (“Rule No. 623/2022”). The Rule establishes tolerance limits for foreign matter in food, as well as the general principles for its establishment and methods of analysis for conformity assessment purposes.
The new Regulation determines the definition of foreign matter and establishes the tolerable parameters for such elements to be in direct contact with food – which applies to the entire production chain – based on the criteria of (i) health risk; (ii) available national data; (iii) occurrence of foreign matters despite the adoption of the best available practices; and (iv) existence of an international reference.
On March 16, 2022, ANVISA published Rule No. 628, of March 10, 2022 (“Rule No. 628/2022”). The Rule establishes the list of coloring substances allowed in personal hygiene products, cosmetics, and perfumes.
The Regulation brings with it the list of substances classified according to “color index number or denomination”, color, field of application and other limitations and requirements.
The field of application can be divided into 4 so-called “columns” — as referred to in the legislation —, namely: (i) column 1, concerning coloring substances allowed in all products; (ii) column 2, concerning coloring substances allowed in all products, except for those applied to the eye region; (iii) column 3, concerning coloring substances allowed exclusively in products that do not come into contact with mucous membranes under regular or reasonably foreseeable conditions of use; and (iv) column 4, concerning coloring substances allowed exclusively in products that have a short time of contact with the skin and hair.
Finally, according to article 10 of the Rule, non-compliance with its provisions constitutes a sanitary violation, under Law No. 6,437/1977.
On March 16, 2022, ANVISA published Normative Rule No. 625, of March 9, 2022 (“Rule No. 625/2022“). The Rule establishes new communication requirements to be complied with by medicine registry holder companies. Such companies must communicate health and consumers authorities when there is: (i) sufficient evidence or indications of deviation from quality that would cause risk or harm to one’s health; or (ii) cancellation of registration due to risk to the safety and efficacy of the drug.
The requirements established in the new Rule will apply if there is “high probability” that the risk or exposure to the drug will cause death, threat to life, permanent damage, temporary damage to health or that is reversible by drug treatment.
The Regulation repeals the former RDC No. 55/2005 and establishes the cases of voluntary and compulsory (determined by the Agency itself), the need to broadcast a warning message to consumers, as well as the monitoring of the collection of products.
On March 25, 2022, the Brazilian Federal Medicine Council published CFM Rule No. 2,306, of March 17, 2022 (“CFM Rule No. 2022”). The Rule establishes the Code of Professional-Ethics Process within the federal scope and of the respective Regional Council.
The new regulation updates the previous Code, for example: rules of competence concerning telemedicine services, the deadline for investigations (up to 90 days, under the terms of article 16, §2), electronic ways to carry out procedural acts and the serving of summons via messaging application.
On April 8, 2022, the MAPA published Rule No. 560, of April 7, 2022 (“Rule No.560/2022”), which waives safety tests with animals in the quality control process of biological products for veterinary use.
The new rule modernizes Brazilian guidelines, in alignment with international standards, in which tests are dispensable, thus reducing the bureaucracy involved in the registration of veterinary products.
No dia On April 5, 2022, the ANS published Rule No. 506, of March 30, 2022 (“RN nº 506/2022”) which establishes the Certification Program of Good Practices in Health Care for Private Health Care Plans Operators.
The Rule aims to improve aspects of the sector such as broader access, quality of health care and beneficiary experience. The Rule also establishes the requirements to recognize accreditation bodies in health, for the certification of good practices, in addition to the required forms for each respective procedure to be carried out.
On April 13, 2022, Law No. 14,323, of April 12, 2022 (“Law No. 14,323/2022”) was passed, which extends fixed-term contracts within the scope of the MAPA and the Brazilian National Supplementary Health Agency (“ANS”).
The purpose of the Law is to ensure that the professionals included in such contracts can carry out their work for a longer period. 215 fixed-term veterinary contracts were extended for another 2 years under the MAPA, and 55 contracts were extended until November 25, 2022 under the ANS.
On April 28, 2022, the Brazilian Ministry of Health published Rule GM/MS No. 947, of April 26, 2022 (“Rule GM/MS No. 947/2022”), which establishes the Code of Ethics for public agents within the Health Ministry.
The Rule applies to all those who effectively carry out a mandate, position, employment or public function (acquired through election, appointment, nomination, or any form of investiture or bond), even if temporarily or without remuneration.
The new Rule establishes practical principles and responsibilities, prohibitions, relationship with the public, standards for interpersonal relationships in the workplace and for the management of ethics. This initiative is important to provide a more comprehensive and effective oversight of public agents and improve the institutional environment.
On March 31, 2022, ANVISA completed the last stage of verification of the Agency’s rules, in compliance with Decree 10,139/2019. The Decree — popularly known as the “Revision Decree” (“Decreto do Revisaço”, in Portuguese) — provides for the revision and consolidation of rules (lower in hierarchy than a decree) of government entities, a procedure that was carried out in five phases.
In the fifth and final stage, ANVISA revised 88 rules, repealed 64 rules and other 58 rules passed ANVISA’s screening. The Agency addressed several topics, such as rules regarding medicines, cosmetics, and sanitizing products.
In addition, Decree No. 10,139/2019 establishes an additional step, during which the Agency must inform which of the revised rules will undergo a more detailed analysis, to assess the merits of the rules.
The deadline for completion of the work related to the “Revision Decree” expires on August 1, 2022.
On March 10, 2022, the Superior Court of Justice (“STJ”) granted the payment of BRL 50,000 in moral damages for denying childbirth coverage to the beneficiary.
The company condemned was Amico Saúde and, according to the Court’s decision, the award of damages applies when there is an unjustified refusal to provide coverage and a legally or contractually agreed procedure.
The Health Plan Operator denied the hospitalization because the area where the hospital is located was not covered.
This is a significant precedent for the sector that could lead to new positive decisions on the same topic.
According to the voting agenda of the Brazilian House of Representatives, Bill No. 1,998/2020, which authorizes and defines the practice of telemedicine throughout the country, is about to be voted on.
Currently, the Project is pending the opinion of the Social Security and Family, and Constitution and Justice and Citizenship Commissions and has seven other bills appended (Bills No. 2,852/20, 4,008/20, 139/21, 766/21, 4,057/21, 4179/21 and 313/22). After being approved in December 2021, the Bill was fast-tracked to the House of Representatives upon an urgency request submitted by representative Luisa Canziani and signed by 36 other representatives.
Currently, the use of telemedicine is temporarily authorized under Law No. 13,989/2020, considering the COVID-19 pandemic. Bill No. 1,998/2020 aims to permanently authorize and regulate telemedicine.
Upon approval of the Bill, the Federal Council of Medicine will become responsible for regulating the minimum procedures for the telemedicine practice. In addition, the Bill will establish that the patient or legal representative must approve the use of the telemedicine, under the professional responsibility of the physician.
On March 22, 2022, the Brazilian National Congress approved the urgency request for voting on the national minimum wage for nurses, technicians and nursing assistants, established in Bill No. 2584/2020.
The proposed amounts are of BRL 4,750.00 for nurses, 70% of that amount for nursing technicians, and 50% for assistants and midwives.
Currently, the Bill is pending the report of the rapporteur of the Committee on Labor, Administration and Public Service, and is set to enter the voting agenda in the Plenary.
On April 26, 2022, the National Congress enacted Constitutional Amendment No. 118, which authorizes the production, marketing, and use of radioisotopes for medical research and use, under the permission regime, by the private sector.
The measure aims to end the State’s monopoly because radioisotopes could be used in treatment of diseases such as cancer.
On April 22, 2022, ANVISA made a request to the Ministry of Health for 15 working days to adopt the measures to amend the normative acts approved by the agency to be maintained after changing the Public Health Emergency of National Importance (ESPIN). The request is based on the principles of precaution and public interest, due to such rules having a relevant impact on society and requiring an appropriate transition period.
On April 12, 2022, the Court of Justice of the State of Rio de Janeiro (“TJRJ”), together with the ANS, signed a Technical Cooperation Agreement to share information between both entities, promote institutional improvement and improve legal enforcement.
The partnership is expected to encourage greater integration, technical-institutional support, and collaboration to solve problems in the supplementary health sector.
On March 11, 2022, the Brazilian Ministry of Agriculture, Livestock and Food Supply (“MAPA”) opened a Public Consultation to gather contributions on criteria for voluntary production, accounting, and trading of green carbon.
The deadline to submit contributions will expire on May 15, 2022, and the texts proposed by MAPA were published in the Federal Official Gazette of Brazil.
Among the proposed rules: (i) two provide for the manufacture of products of animal origin (Rules No. 255 and No. 256); (ii) two provide for products of plant origin (Rules No. 257 and No. 258); (iii) another rule regulates the capture and storage of carbon through the processing of livestock products (Rule No. 260); and (iv) one final rule aims to establish the criteria for the production, accounting and remuneration for green carbon (Rule No. 254).
The purpose of the Regulations is to develop a voluntary market for green carbon credits in Brazil. The technical rules to be published will follow nationally validated decarbonizing methodologies and principles, such as those defined by the ABC+ Plan. Currently, the use of concepts such as zero carbon, low carbon and neutral carbon is carried out by brands on an unregulated basis.
With the new regulation issued by MAPA, the existing voluntary carbon market will have clear criteria and methodologies aimed at consumer protection.
On April 11, 2022, ANVISA published Public Contribution Collection No. 6, of April 11, 2022 (“TPS No. 6/2022”), which made public, from April 11, 2022, the receipt of contributions concerning technical and scientific evidence on the efficacy of electronic cigarettes.
Interested parties can submit their contributions until May 11, 2022, through this link, which also enables access to the partial report and the contribution form.